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| Reference: | 4974 |
| Country: | Kenya |
| Multiple country event: | No |
| Region: | AFRO |
| City: | Kisumu |
| Start date: | 2 February 2013 |
| End date: | 16 February 2013 |
| Estimated duration: | |
| Status: | Completed - Complété |
| | (The mission has taken place) |
|
| Title: | To plan for training and implementation of the upcoming study of TB diagnostics in children in Nyanza Province, Kenya. |
| Type: | Mission |
| Terms of Reference: | In high burden settings, TB is an important cause of disease and death among children and a preventable cause of
under-5 mortality; HIV infection is an important risk factor for TB disease and is associated with an increased risk of
death. However, it is difficult to confirm the diagnosis of TB in children. Identification of improved methods of TB
diagnosis for children has been identified as a research priority by the WHO.
Preparations are underway for a study in Nyanza District, Kenya, in collaboration with KEMRI/CDC and Harvard
University, to determine the optimal approach to laboratory diagnosis of TB disease in children by systematically
applying currently available diagnostic tests to a panel of specimens in the evaluation of children both with and
without HIV infection. In addition, test characteristics of emerging diagnostic tools for TB will simultaneously be
assessed. Understanding the optimal approach to laboratory diagnosis of TB in children will allow establishment of
an improved approach to diagnosis against which new approaches to diagnosis and screening can be compared.
The goal of this TDY was to support activities related to the training, piloting, and implementation of this study.
Outcomes and Accomplishments
Piloting: A pilot stage for the study will begin on February 20, 2013. A training schedule for the pilot was
established and lectures were prepared accordingly. The scope of the pilot will be limited to a subset of the
specimens and tests that will comprise the full study, namely gastric aspirate, urine, and stool testing. The pilot will
allow for testing of the case report forms, database, and specimen collection techniques on the clinical side. The
laboratory will also have the opportunity to finalize specimen preparation and processing techniques in advance of
the full study. Testing will be limited to microscopy, culture, Xpert, and urine LAM dipsticks.
Procurement of supplies: Suppliers for clinical and laboratory consumables have been identified and, for most of
these supplies, the local admin team has coordinated with the procurement team to place purchase orders for these
items. A limited number of study supplies are not available locally and efforts are underway to procure them from
vendors outside of Kenya.
Data: An electronic, web-based database is being designed by the KEMRI/CDC data team. We met with the data
staff to review the data entry screens, algorithms for screening, and laboratory interface. Additional modifications are
being made in anticipation of a pilot stage of the study. Also, a system for bar-code labeling of specimens was
designed.
Documentation: Standard operating procedures (SOPs) and other study documents are currently being finalized
with a focus on those SOPs that will need to be ready for the pilot. Where possible, existing KEMRI/CDC SOPs are
being used or, if needed, revised to apply as well to procedures for the study. SOPs were reviewed and sent for
finalization by KEMRI/CDC TB Branch quality assurance officers (general and laboratory). Finalized SOPs were
compiled in a repository for study documentation.
Clinical sites: Meetings were held with the hospital superintendant and pediatric ward charge nurse at one of the
study sites. Topics discussed included the compensation to the hospital for admitting study patients, supplies that
will be brought to the hospital through the study, and plans to incorporate the local nursing staff in the training and
activities of the study. |
| Training Opportunity: | No |
| Website: | |
| Purpose 1: | Childhood TB |
| Purpose 2: | |
| Purpose 3: | |
| Other purpose: | |
|
| Entered by: | Center for Disease Control and Prevention (CDC) |
| Partner 1: | |
| Partner 2: | |
| Partner 3: | |
| Contact name: | Sara Auld |
| Contact email: | via1@cdc.gov |
| Other agencies: | |
|
| Funding needs: | No |
| Funding source: | |
| Other funding source: | |
| Available funding: | $ 0 |
| Funding gap: | $ 0 |
| Global Fund reference: | |
|
| Comments: | |
| |
There are no experts (roster) associated with this event. There are no experts (non-roster) associated with this event.
Date Created: 6 March 2013
Entered By: CDC
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